A Prospective, Double-Blind, Randomized Controlled study Assessing the Perioperative Glycemic Response following Two Doses of Dexamethasone for Postoperative Nausea and Vomiting Prophylaxis in Gynecological Laparoscopic Surgeries.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Blood sugar values
研究概览
简要总结
Double blinded, randomized, controlled study,Written informed consent will be taken from willing patients posted for elective surgery under general anesthesia. Pre operative blood sugar values will be documented along with age, gender,body mass index, type of surgery.Double blinding will be ensured by using preloaded 2 ml syringe of dexamethasone of 4 mg (groupA) and Dexamethasone 8mg (group B), prepared by an anesthesia resident unaware of allocation, after the opening of a sealed opaque envelope containing the randomized assignment. Patients will be allocated in 2 groups: non-diabetics receiving Dexamethasone 4mg ; Non diabetics receiving dexamethasone 8mg.The study drug will be administered after induction of anesthesia. No dextrose containing solution will be administered during the study. In the OT after attaching standard ASAmonitors, anesthesia will be induced with propofol iv after premedication with intravenousglycopyrrolate, Midazolam, ondansetron 4mg, fentanyl. Muscle relaxation will be achieved with atracurium 0.5mg/kg and endotracheal intubation done. At the end of surgery patients will be extubated after reversal of neuromuscular blockade. For the patient intraoperatively blood glucose monitoring will be done as per protocol.All blood glucose levels will be measured using a calibrated glucometer, SD code free (SD Biosensor,Inc.).The blood glucose measurements will be obtained from finger prick capillary blood samples, by anaesthesiology resident blinded to study group The total amount of insulin administered for the treatment of perioperative hyperglycemia will be recorded .
Blood sugar values after dexamethasone administration on POD 1,2,3 will be taken as primary endpoints.
PONV will be assessed using a 4-point verbal descriptive scale which consists of score 0=no
PONV, score1 = mild PONV: patient complaints of nausea but refuses antiemetic treatment, score 2
= moderate PONV: patient complaints of nausea and needs antiemetic treatment; score 3= severe
PONV.
Patients who experience PONV in the recovery area will be treated with
intravenous metoclopramide (10 mg)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •ASA-1,ASA-2 patients undergoing elective laparoscopic surgeries under general anaesthesia Non-diabetic patients Hba1c less than 5.6 Bodymassindex less than 30kg/m2.
排除标准
- •Preoperative use of corticosteroids, insulin Pregnancy Preoperative fasting blood glucose levels more than 126mg/dl,Hba1c more than 6.5, Malignancy, Immunosuppression,Diabetic patients.
结局指标
主要结局
Blood sugar values
时间窗: 1st hour,2nd hr,3rd hr After dexamethasone Administration.
次要结局
- Post operative nausea & vomiting(Post operative period 8th hour,POD 1 2 3)
研究者
Dr Bandari Vamshi sai
Rajarajeswari medical college and hospital
